U.S. patent application number 10/337572 was filed with the patent office on 2004-05-20 for transcutaneous nerve and muscle stimulator and method of using the same.
This patent application is currently assigned to Alliance Health Products, LLC. Invention is credited to Abercrombie, Chad E., Hagglof, James T., Rosenquist, Scott D..
Application Number | 20040098065 10/337572 |
Document ID | / |
Family ID | 32303455 |
Filed Date | 2004-05-20 |
United States Patent
Application |
20040098065 |
Kind Code |
A1 |
Hagglof, James T. ; et
al. |
May 20, 2004 |
Transcutaneous nerve and muscle stimulator and method of using the
same
Abstract
A transcutaneous electrical stimulator system includes a small,
lightweight, portable, external, programmable transcutaneous
electrical stimulator that provides multiple electrical stimulation
therapies to a patient through the patient's skin. The stimulator
includes persistent, modifiable memory programmable by a
practitioner for prescribing multiple electrical stimulation
therapies for the patient. A programming pod is configured to
interface with the stimulator and a computer to program multiple
stimulation therapies into the persistent, modifiable memory of the
stimulator.
Inventors: |
Hagglof, James T.;
(Monument, CO) ; Abercrombie, Chad E.; (Monument,
CO) ; Rosenquist, Scott D.; (Colorado Springs,
CO) |
Correspondence
Address: |
PROCOPIO, CORY, HARGREAVES & SAVITCH LLP
530 B STREET
SUITE 2100
SAN DIEGO
CA
92101
US
|
Assignee: |
Alliance Health Products,
LLC
|
Family ID: |
32303455 |
Appl. No.: |
10/337572 |
Filed: |
January 7, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60427866 |
Nov 19, 2002 |
|
|
|
60432180 |
Dec 10, 2002 |
|
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Current U.S.
Class: |
607/48 |
Current CPC
Class: |
A61N 1/37247 20130101;
A61N 1/36021 20130101; A61N 1/3603 20170801 |
Class at
Publication: |
607/048 |
International
Class: |
A61N 001/18 |
Claims
What is claimed is:
1. A transcutaneous electrical stimulator system for use with a
computer, comprising: a small, lightweight, portable, external,
programmable transcutaneous electrical stimulator that provides
multiple electrical stimulation therapies to a patient through the
patient's skin, the stimulator including persistent, modifiable
memory programmable by a practitioner for prescribing multiple
electrical stimulation therapies for the patient; and a programming
pod configured to interface with the stimulator and the computer to
program multiple stimulation therapies into the persistent,
modifiable memory of the stimulator.
2. The transcutaneous electrical stimulator system of claim 1,
wherein the stimulator and the programming pod are configured to
transmit one or more of the following to the computer: a stimulator
performance report, stimulator error codes, checksum discrepancies,
stimulator power level, and stimulator diagnostic information.
3. The transcutaneous electrical stimulator system of claim 1,
wherein the stimulator includes a length, a width, and a height,
and the stimulator includes at least one of the following: the
length is no greater than 1.05 in., the width is no greater than
1.65 in., and the height is no greater than 0.30 in.
4. The transcutaneous electrical stimulator system of claim 1,
wherein the stimulator includes a 3 V lithium coin cell battery to
power the stimulator.
5. The transcutaneous electrical stimulator system of claim 1,
wherein the stimulator includes a power source no larger than a 3 V
lithium coin cell battery to power the stimulator.
6. The transcutaneous electrical stimulator system of claim 1,
wherein the stimulator includes one or more practitioner
controllable inputs requiring a specific input selection procedure
to prevent patient control of all aspects of delivery of the
multiple therapies except for on/off control of the stimulator.
7. The transcutaneous electrical stimulator system of claim 6,
wherein the one or more practitioner controllable inputs control
intensity of the multiple therapies.
8. The transcutaneous electrical stimulator system of claim 1,
wherein the stimulator delivers a micro-current therapy waveform
suitable for edema reduction.
9. The transcutaneous electrical stimulator system of claim 1,
wherein the stimulator includes a microcontroller, and the
persistent, modifiable memory is embedded in the
microcontroller.
10. The transcutaneous electrical stimulator system of claim 9,
wherein the persistent, modifiable memory includes operating
software for the stimulator, the persistent, modifiable memory
reprogrammable for adding operating software upgrades or different
operating software.
11. The transcutaneous electrical stimulator system of claim 1,
further including one or more electrodes configured to carry the
stimulator and be applied with the stimulator to an area of the
body to be treated with the multiple therapies.
12. The transcutaneous electrical stimulator system of claim 1,
wherein the stimulator includes one or more stimulator electrode
contacts, and the pod includes one or more corresponding pod
electrical contacts that electrically communicate with the one or
more stimulator electrode contacts when the stimulator is
interfaced with the pod for performing stimulator diagnostics.
13. A method of programming multiple electrical stimulation
therapies into a transcutaneous electrical stimulator at a
practitioner location, comprising: providing at the practitioner
location a small, lightweight, portable, external, programmable
transcutaneous electrical stimulator that provides multiple
electrical stimulation therapies to a patient through the patient's
skin, the stimulator including persistent, modifiable memory
programmable by a practitioner for prescribing multiple electrical
stimulation therapies for the patient; providing at the
practitioner location a programming pod interfaced with the
stimulator to program multiple stimulation therapies into the
persistent, modifiable memory of the stimulator; providing at the
practitioner location a computer interfaced with the programming
pod to program multiple stimulation therapies into the persistent,
modifiable memory of the stimulator via the programming pod; using
the computer at the practitioner location to program multiple
therapies into the persistent, modifiable memory of the stimulator
via the programming pod.
14. The method of claim 13, further including verifying with the
stimulator interfaced with the programming pod that the stimulator
is operating correctly before applying the stimulator to the
patient.
15. The method of claim 13, further including using the stimulator
to deliver multiple electrical stimulation therapies to the
patient, returning the stimulator to the practitioner, and
reprogramming the stimulator through the enumerated steps of claim
13.
16. The method of claim 13, further including using the stimulator
to deliver multiple electrical stimulation therapies to the
patient, transferring the stimulator to a refurbishing location,
and refurbishing the stimulator.
17. The method of claim 13, wherein separately programming each
therapy of the multiple therapies includes programming a
micro-current therapy waveform into the stimulator suitable for
edema reduction, and further including using the stimulator to
deliver the programmed micro-current therapy waveform to the
patient for edema reduction.
18. The method of claim 13, wherein the stimulator includes one or
more practitioner controllable inputs requiring a specific input
selection procedure to prevent patient control of all aspects of
delivery of the multiple therapies except for on/off control of the
stimulator.
19. The method of claim 13, wherein the stimulator includes one or
more practitioner controllable inputs that control intensity of the
multiple therapies, and the method further includes applying the
stimulator to the patient, and the practitioner controlling the
intensity of each therapy of the multiple therapies using a
specific input selection procedure, which is not known to the
patient, involving the one or more practitioner controllable
inputs.
20. A computer readable medium having stored thereon one or more
sequences of instructions for causing one or more microprocessors
to perform the steps for programming multiple electrical
stimulation therapies into a transcutaneous electrical selecting a
specific therapy to be programmed out of multiple sequential
electrical stimulation therapies; selecting one of multiple
different types of predetermined therapies and a custom therapy;
selecting a type of polarity for the stimulator; selecting a time
duration of the therapy; selecting an idle time duration between
therapies; selecting the next specific therapy to be programmed out
of multiple sequential electrical stimulation therapies and
repeating the above steps until all the therapies of the multiple
sequential electrical stimulation therapies are input; selecting
one of a repeat function to cause the stimulator to cycle through
multiple therapies then repeat and a terminate function to cause
the stimulator to cycle through multiple therapies then stop; and
selecting a program function to cause the programming pod to
program the multiple electrical stimulation therapies into the
transcutaneous electrical stimulator.
Description
FIELD OF THE INVENTION
[0001] The present invention is, in general, in the field of
medical transcutaneous stimulators that provide an electrical
stimulation signal in the form of a continuous or interrupted train
of pulses to a patient for nerve and muscle stimulation, and edema
reduction.
BACKGROUND OF THE INVENTION
[0002] Medical stimulators that provide electrical stimulation
signals to a patient are used to provide short and long term pain
relief through transcutaneous electrical nerve stimulation ("TENS")
and to stimulate and rehabilitate muscles through neuromuscular
stimulation ("NMS" or "EMS"). As used herein, a "transcutaneous
electrical stimulator" includes at least a TENS stimulator, a NMS
or EMS stimulator, a stimulator used for edema reduction or any
other medical stimulator used to transcutaneously deliver
therapeutic electrical impulses. These types of medical stimulators
typically include lead wires with distal electrodes that are
attached to the patient's skin. The transcutaneous electrical
stimulator sends electrical stimulation signals into the muscles
and nerves though the attached electrodes. The electrical
stimulation signals produced by the transcutaneous electrical
stimulator are in the form of a train of electrical pulses which
may be modulated in rate and/or intensity.
[0003] Transcutaneous electrical stimulators may use a periodic
treatment mode and/or a continuous treatment mode. The periodic
treatment mode includes an on time cycle and an off time cycle.
During the on time cycle, a train of pulses forming the stimulation
signal is delivered, and during the off time cycle, no pulses are
delivered. The continuous treatment mode includes a continuous
train of pulses provided as output.
[0004] A problem with conventional transcutaneous electrical
stimulators is that they include controls on the stimulators for
setting the proper and unique operation of the transcutaneous
electrical stimulator. Some patients may try to alter the controls
without understanding the effect of such alterations, causing
ineffective or destructive electrical stimulation signals to be
delivered.
[0005] Another problem with conventional transcutaneous electrical
stimulators is that they deliver electrical stimulation signal
patterns, treatment periods, and frequencies inappropriate for the
complexity of the muscles.
[0006] A further problem is that transcutaneous electrical
stimulators do not allow for fast, easy programming of appropriate
electrical stimulation signal patterns, treatment periods, and
frequencies in the transcutaneous electrical stimulator.
[0007] A still further problem with transcutaneous electrical
stimulators is that they tend to be rather large and bulky, making
them uncomfortable to wear. Transcutaneous electrical stimulators
can also be very time intensive for patients if they need to visit
a practitioner on a frequent basis for treatment using a
transcutaneous electrical stimulator.
SUMMARY OF THE INVENTION
[0008] An aspect of the invention involves a transcutaneous
electrical stimulator system for use with a computer. The
transcutaneous electrical stimulator system includes a small,
lightweight, portable, external, programmable transcutaneous
electrical stimulator that provides multiple electrical stimulation
therapies to a patient through the patient's skin. The stimulator
includes persistent, modifiable memory programmable by a
practitioner for prescribing multiple electrical stimulation
therapies for the patient. A programming pod is configured to
interface with the stimulator and the computer to program multiple
stimulation therapies into the persistent, modifiable memory of the
stimulator. One of many unique firmware executables (standard,
special, or custom) may also be programmed into memory of the
stimulator. Each unique firmware executable may include its own
protocol for sequence of therapies and/or intensities.
[0009] Another aspect of the invention involves a method of
programming multiple electrical stimulation therapies into a
transcutaneous electrical stimulator at a practitioner location.
The method includes providing at the practitioner location a small,
lightweight, portable, external, programmable transcutaneous
electrical stimulator that provides multiple electrical stimulation
therapies to a patient through the patient's skin, the stimulator
including persistent, modifiable memory programmable by a
practitioner for prescribing multiple electrical stimulation
therapies for the patient; providing at the practitioner location a
programming pod interfaced with the stimulator to program multiple
stimulation therapies into the persistent, modifiable memory of the
stimulator; providing at the practitioner location a computer
interfaced with the programming pod to program multiple stimulation
therapies into the persistent, modifiable memory of the stimulator
via the programming pod; and using the computer at the practitioner
location to program multiple therapies into the persistent,
modifiable memory of the stimulator via the programming pod.
[0010] A further aspect of the invention involves a computer
readable medium having stored thereon one or more sequences of
instructions for causing one or more microprocessors to perform the
steps for programming multiple electrical stimulation therapies
into a transcutaneous electrical stimulator via a programming pod.
The steps include selecting a specific therapy to be programmed out
of multiple sequential electrical stimulation therapies; selecting
one of multiple different types of predetermined therapies and a
custom therapy; selecting a type of polarity for the stimulator;
selecting a time duration of the therapy; selecting an idle time
duration between therapies; selecting the next specific therapy to
be programmed out of multiple sequential electrical stimulation
therapies and repeating the above steps until all the therapies of
the multiple sequential electrical stimulation therapies are input;
selecting one of a repeat function to cause the stimulator to cycle
through multiple therapies then repeat and a terminate function to
cause the stimulator to cycle through multiple therapies then stop;
and selecting a program function to cause the programming pod to
program the multiple electrical stimulation therapies into the
transcutaneous electrical stimulator.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a schematic diagram of an embodiment of a
transcutaneous electrical stimulator system, a computer, and a
printer.
[0012] FIG. 2A is a front perspective view of an embodiment of a
small, portable, external, programmable transcutaneous electrical
stimulator that may be used as part of the system illustrated in
FIG. 1.
[0013] FIG. 2B is a rear perspective view of the stimulator of FIG.
2A.
[0014] FIG. 2C is a front perspective view of an embodiment of
self-adhesive electrodes that may be used with the stimulator of
FIG. 2A.
[0015] FIG. 2D is a front perspective view of an embodiment of a
docking pod or cradle that may be used with the stimulator of FIG.
2A.
[0016] FIG. 2E is a block diagram of an embodiment of electronics
that may be used in the stimulator of FIG. 2A.
[0017] FIG. 2F is a block diagram of an embodiment of electronics
that may be used in the docking pod of FIG. 2D.
[0018] FIG. 3 illustrates waveforms of an example transcutaneous
stimulation therapy and waveforms of a recharge interval during
which the stimulator may be recharged.
[0019] FIG. 4 is a table illustrating an embodiment of therapy
parameters that may be programmed into the stimulator.
[0020] FIG. 5 is a table illustrating exemplary locations in EEPROM
memory where information on therapy parameters may reside.
[0021] FIGS. 6-8 illustrate an exemplary dialog box that may be
used in the programming of the stimulator, and show fields for text
entry or therapy parameter selection.
[0022] FIG. 9 is a block diagram illustrating an exemplary computer
as may be used in connection with various embodiments described
herein.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0023] With reference initially to FIGS. 1 and 2, a small,
lightweight, portable, external, programmable transcutaneous
electrical stimulator (hereinafter "stimulator") 10 constructed in
accordance with an embodiment of the invention and which may be
used as part of a transcutaneous electrical stimulator system 20
will be described. The stimulator 10 may be used externally to
provide electrical stimulation signals to a patient. As used
herein, "external" or "externally" means the stimulator 10 is
non-implantable and the electrical stimulation signals are
delivered from outside the patient's body (i.e. typically via one
or more electrodes affixed to the patient's skin) transcutaneously,
through the patient's skin. The electrical stimulation signals may
be used to provide short and long term pain relief through
transcutaneous electrical nerve stimulation ("TENS"), to stimulate
and rehabilitate muscles through neuromuscular stimulation ("NMS"),
and/or to provide pseudo-random bipolar low-intensity microcurrent
stimulation for edema reduction.
[0024] Before specifically describing the stimulator 10, the
overall system 20 will be described generally. The system 20
includes the stimulator 10 and a docking station or pod 30 residing
at a medical practitioner's office. The pod 30 may be
communicatively coupled to a personal or laptop computer 40
(hereinafter "computer") through one or more connections 50 such
as, but not by way of limitation, a serial connection (e.g., RS232,
USB), a parallel connection, and/or network. One or more output
devices at the practitioner's office such as a printer 60 for
printing reports 70 related to the stimulator 10 may be
communicatively coupled to the computer 40 through one or more
connections 75 such as, but not by way of limitation, a parallel
connection and/or a network. The computer 40 may be used to program
one or more electrical stimulation therapies and/or operating
software (or operating software upgrades) into the stimulator 10
(via the pod 30). The computer 40 and the pod 40 may also be used
to receive data from the stimulator 10 such as, but not limited to,
a summary report of the performance history of the stimulator 10
since the last programming/docking, any error codes that may have
occurred during performance of the stimulator 10, any checksum
discrepancies that may have occurred during performance of the
stimulator 10, battery power level in the stimulator 10, and
stimulator diagnostic and verification information.
[0025] With reference to FIGS. 2-5, and initially to FIG. 2A, the
stimulator 10 and pod 30 will be described in more detail. In the
embodiment shown, the stimulator 10 has a generally rectangular
block-shaped housing 80. Corners 90 of the housing 80 may be
rounded to give the stimulator 10 a more rounded ergonomic look and
feel. In a preferred embodiment, the stimulator 10 is much smaller
and lighter than TENS devices used in past (TENS devices used in
the past were generally about the size of a Sony.RTM. Walkman.RTM.
cassette player; the batteries used in the prior art TENS devices
were often larger than the stimulator 10 described herein) and
includes a length L of 1.05 in., a width W of 1.65 in., and a
height H of 0.30 in. The stimulator 10 is considerably smaller,
lighter, less cumbersome, and less noticeable to the user or
patient than stimulators used in the past, increasing the comfort
of the patient and increasing the chances that the patient will use
the stimulator 10. In alternative embodiments, the stimulator 10
may include one or more dimensions smaller than those specified
above.
[0026] The stimulator 10 may operate on a single, disposable, very
small 3V lithium coin cell battery 92 (FIG. 2E). Although a single
coin cell 3V battery is described, other power sources, smaller
power sources, or other numbers of power sources may be used.
Because of the prescription nature of the programmable stimulator
10, the battery is preferably disposable and not replaceable by the
patient.
[0027] In an embodiment of the invention, the stimulator 10 is
returned to the practitioner upon a return visit or appointment
with the practitioner. The stimulator 10 may then be sent by the
practitioner to a third party, where the stimulator 10 is
refurbished. Refurbishing of the stimulator 10 by the third party
may include removal and responsible environmental disposal of the
battery, replacement of the battery with a new battery, and
stimulator integrity verification. The stimulator 10 may then be
sold or shipped to another practitioner for prescription
programming/reprogramming and use with another user or patient.
[0028] In another embodiment of the invention, the stimulator 10 is
returned to the practitioner upon a return visit or appointment
with the practitioner. The stimulator 10 may be refurbished by the
practitioner by replacing the battery. The stimulator 10 may be
reprogrammed and/or integrity verified, and then issued to the same
or a different user or patient.
[0029] The stimulator 10 may provide unipolar (positive or
negative) or bipolar (positive and negative) pulsed energy
waveforms for localized pain control or muscle stimulation. In a
preferred embodiment, the only patient-controllable input on the
stimulator 10 may be an "A" button on a front 107 of the stimulator
10 that toggles the current programmed therapy on or off, and a "B"
button that may be pressed while the stimulator 10 is in an active
mode to display the programmed therapy number via a mode indicator
110 such as a green LED. Once the "B" button is pressed, the
indicator 110 may flash a number of times associated with the
programmed therapy number (e.g., when the stimulator is on therapy
four, the indicator 110 may flash four times). The "A" button may
also be used for controlling the mode of the stimulator 10 and the
"B" button may be used for controlling auxiliary functions once the
stimulator 10 is in a specific mode.
[0030] A power switch 100 located in a connector compartment 102 on
a rear 103 of the stimulator 10 may control the supply of power
from the battery to the electronics of the stimulator 10. The power
switch 100 may be maintained in an off position when the stimulator
10 is shipped and stored, i.e., until the stimulator 10 is
programmed by a qualified practitioner, prior to being applied to
the patient, preventing drainage of the battery. Pod programming
connections or connector 104 (e.g., a ten-pin connector) may be
located in the connector compartment 102 for mechanically and
electrically coupling the stimulator 10 to the pod 30. A detachable
compartment cover 106 may be used to cover the compartment 102. On
an opposite end of the housing 80, the stimulator 10 may include a
pair of protruding electrode pins 130.
[0031] Once the stimulator 10 has been programmed and removed from
the pod 30, the one or more electrodes 170 (FIG. 2C) have been
connected to the stimulator 10 and the patient, and the power
switch 100 has been switched to the on position, the "A" button may
be pressed by the practitioner for a certain period of time (e.g.,
5 seconds or longer) to enable intensity control for a first
therapy, then the "B" button may be held or pressed multiple times
to control the intensity level of the stimulator 10 for each
specific programmed therapy (e.g., 15 specific therapies). The
stimulator 10 may provide up to 52 V into 500 Ohms (104 mA) or 84 V
into 1000 Ohms (84 mA). The stimulator 10 includes fine control of
intensity with the capability of more than 50 incremental intensity
steps between 2 V and 52 V. Each press of the "A" button may cause
the stimulator 10 to cycle to the next programmed therapy for
adjusting the intensity.
[0032] Although a pair of buttons 120 are shown, in alternative
embodiments, other numbers of inputs, different inputs, and/or a
different procedure may be used for enabling intensity control and
adjusting intensity control of the stimulator 10 for each therapy.
For example, the "A" and "B" buttons may be pressed in a unique
combination to enable intensity control, to control intensity level
for each therapy, to put the stimulator 10 in a manual mode, and/or
to put the stimulator 10 in an automatic mode.
[0033] The inventors have determined that requiring a unique input
selection procedure to enable and control intensity of the
stimulator 10 (i.e., locking the patient out from controlling the
intensity) makes it convenient for the practitioner to adjust
intensity levels for each therapy and prevents the patient from
manually adjusting the intensity of the electrical signals to an
ineffective and/or dangerous level. In an alternative embodiment,
if the practitioner is comfortable with giving the patient control
of the intensity of the stimulator, the practitioner may disclose
the unique input selection procedure to the patient to allow the
patient to enable and control intensity of the stimulator 10.
[0034] Once the intensity level of each therapy is adjusted to a
desired level, the stimulator 10 may be put back into an automatic
mode through a unique keypress input selection (e.g., the "A"
button may be held for 10 seconds or longer), activating each
therapy at their respective programmed intervals until the therapy
terminates or repeats.
[0035] With reference to FIG. 2E, a block diagram of an embodiment
of the main electrical components of the stimulator 10 of FIG. 2A
is shown. The stimulator 10 is powered from the very small 3V
lithium coin cell battery 92. Because the controller firmware
executes when powered, the battery switch 100 is used to preserve
battery life until the stimulator 10 is programmed and ready for
use. The stimulator 10 is interfaced with the pod 30 through the
multi-contact pod programming connections 104 and is programmed
externally by the programming pod 30. An embedded microcontroller
142 programmed by the external pod 30 contains flash (program or
operating) memory, EEPROM therapy memory, and an internal
oscillator for pulse recharge and output control, which is
determined by each programmed therapy. In alternative embodiments,
other types of persistent, modifiable memory other than the flash
memory and the EEPROM may be used or other types of memory may be
used.
[0036] Because the flash memory and EEPROM memory are
reprogrammable by the computer 40 via the pod 30, not only can the
EEPROM memory of the stimulator 10 be reprogrammed for different
therapies and different therapy combinations, but the operating
software in the flash memory may also be easily reprogrammed,
eliminating the need to purchase a new stimulator 10 for
programming software upgrades. Multiple unique firmware executables
(standard, special, or custom) may be made available to qualified
practitioners, selected by application software on the computer 40,
and programmed into flash memory of the stimulator 10 through the
pod 30. Each unique firmware executable may include its own
protocol for sequence of therapies and/or intensities. Executables
may provide additional flexibility of programmed parameters over
those described herein (e.g., may allow for pseudo-random waveforms
and intensities). If all aspects of programmability can not be
maintained in one executable executables) may be separately
programmed into the stimulator 10 as needed (e.g., one executable
may support multiple TENS and EMS therapies, another executable may
support pseudo-random uni-polar or bi-polar stimulation signaling
and possible fixed pseudo-random excitation). Operating software
upgrades can also be easily made to the stimulator 10 through the
pod 30.
[0037] Both positive 144 and negative 146 charge control circuits
utilize switching boost converter topologies which can achieve up
to 100 V (no-load) of capacitively stored charge energy. Each
circuit 144, 146 utilizes very small surface mount inductors,
capacitors, resistors and switching bipolar and MOSFET transistors
to achieve extremely small circuit size. The amount of charge is
determined by the programmed charge intensity for each programmed
therapy. Positive pulse control 148 and negative pulse control 152
circuits deliver output pulses to a charge combining circuit 154,
as determined by each programmed therapy. The output pulses are
delivered to the two male pin electrode pins 132, to which
electrodes 170 (e.g., standard or custom skin surface electrodes)
may be attached. Once the stimulator 10 is programmed by the
programming pod 30, the mode button "A" and the auxiliary Button
"B" may be used to select and set the intensity of each programmed
therapy.
[0038] With reference to FIG. 2C, in an exemplary embodiment, the
electrodes 170 are patient-approved, self-adhesive conductive
electrodes. Each electrode 170 may include a connector sleeve 132
that slidably receives the electrode pin 130 of the stimulator 10.
The sleeve 132 is connected via a lead wire 180 to a distal
self-adhesive electrode patch 190. The distal self-adhesive
electrode patch 190 may be affixed to the patient's skin. The
stimulator 10 sends electrical stimulation waveform signals into
the muscles and nerves though the one or more electrodes 170.
[0039] In alternative embodiments, other types of electrodes may be
used. For example, but not by way of limitation, in another
embodiment of the invention, the practitioner programmable
stimulator 10 may be physically applied to the patient's body by
way of a custom patient-approved adhesive pouch or holster with the
electrode(s) at or near the area of pain or discomfort. Wireless
snap electrodes or the like may fit onto the electrode pins 130 of
the stimulator 10. In this embodiment, the electrode pins 130 may
have a different configuration and/or be located at a different
location on the housing 80 than that shown in FIG. 2A. The wireless
snap electrodes may be self adhesive and may include a pouch,
holster, or other carrying mechanism configured to carry the
stimulator 10. The wireless snap electrodes, which carry the
stimulator 10, are applied to the patient's skin over the area of
pain or discomfort with the stimulator 10. The unique, small,
lightweight construction of the practitioner programmable
stimulator 10 allows the stimulator 10 to be applied to the local
area of pain or discomfort on the patient's body with the
electrodes.
[0040] With reference to FIG. 2D, the pod 30 may include a
generally rectangular, block-shaped base 200 with a generally
rectangular, block-shaped recess 202 on an upper surface 204 that
forms a stimulator bay 210 sized and shaped to receive the
stimulator 10. The simulator bay 210 may include a bottom surface
212, a front wall 214, a rear wall 216, a left-side wall 218, and a
right-side wall 220. The bottom surface 212 may include pod
programming connections 222 (FIG. 2F) near the front wall 214 that
mate with the pod programming connections 104 of the stimulator 10
when the stimulator 10 is docked with the pod 30 to form a
communication connection. The rear wall 216 may include electrode
pin contacts 224 that receive the electrode pins 130 of the
stimulator 10. A front panel 226 of the pod 30 may include one or
more status indicators 228 (e.g., one or more of the same or
different colored LEDs) to indicate the status of the pod 30. A
rear panel (not shown) of the pod may include an on/off switch, a
power input, and a communications connection to communicatively
couple the pod 30 to the computer 40. The base 200 of the pod 30
may rest on fixed supports 230 extending from an undersurface of
the base 200.
[0041] With reference to FIG. 2F, a block diagram of an embodiment
of the main electrical components of the pod of FIG. 2D is shown.
The pod 30 is powered by an AC to DC converter 232. Power from the
converter 232 to the pod 30 may be controlled with an on/off switch
234 or may be controlled on/off by sensing data communication from
the host computer (e.g., USB activity) and regulated by a linear
DC-to-DC Regulator 236, providing DC power to the pod electronics.
The computer 40 interfaces to the pod 30 over serial (USB or RS232)
or parallel (LTP) physical protocols. A microcontroller 238 manages
software protocol from the computer 40 and controls programming of
the stimulator 10. A digital to analog converter ("DAC") 240
converts the signal and supplied it to the positive supply circuit
241 for controlling the programming voltage(s) to the stimulator
10. A digital buffer 242 and pod programming driver circuits 244
buffer the programming signals to and from the stimulator 10. An
analog-to-digital converter ("ADC") 246 and analog conditioning
circuits 248 provide measurements of the stimulator battery 92 and
electrode output voltages from the pod programming connections 250
and the electrode pin contacts 224.
[0042] Through the pod programming connections 222 (FIG. 2F), the
pod 30 may be used to program the stimulator 10, supply power to
the stimulator 10 while the simulator 10 is docked, measure battery
power, transmit and receive information in addition to programming
information (e.g., diagnostic, verification, stimulator history
such as the number of times the stimulator 10 has been turned on
and off, checksum discrepancies).
[0043] With reference to FIG. 5, the EEPROM of the embedded
microcontroller 142 is programmed by the external pod 30 for
storing parameters related to each programmed therapy. In an
exemplary embodiment, the EEPROM may include an array of 64
registers of 16 bit (8 bits (MSB)+8 bits (LSB)) memory locations,
each therapy utilizing 8 bytes or 64 bits. The table of FIG. 5
shows where the parameters for a particular therapy may be stored
in memory. At an array location of Index+0, the THERAPY TYPE
parameter is stored in the first 8 bits (MSB 0) of the register and
the THERAPY TIME parameter is stored in the second 8 bits (LSB 0)
of the register. At an array location of Index+1, the IDLE COUNT
parameter is stored in the first 8 bits (MSB 1) of the register and
the PULSE PERIOD parameter is stored in the second 8 bits (LSB 1)
of the register. At an array location of Index+2, the PULSE STYLE
parameter is stored in the first 8 bits (MSB 2) of the register and
the RECHARGE CONFIG is stored in the second 8 bits (LSB 2) of the
register. At an array location of Index+3, the RECHARGE COUNT
parameter is stored in the first 8 bits (MSB 3) of the register and
the CHECK
[0044] With reference to FIG. 4, the different therapy parameters
that may be stored in persistent, modifiable memory of the EEPROM
of the stimulator 10 will now be described in more detail.
[0045] The THERAPY TYPE parameter indicates the type of electrical
stimulation therapy the stimulator 10 is to perform with the b bit
indicating whether bipolar treatment should be performed (if
bipolar treatment is to be performed, this overrides the c bit
described below), the c bit indicating whether the polarity is
positive or negative, the d bit indicating whether the therapy
should be repeated after it is performed or stop after it is
performed), and the four eeee bits indicating which of the 15
specific therapy types is to be performed.
[0046] The THERAPY TIME parameter indicates the duration of the
therapy in 1 minute increments and ranges from 1 minute to 240
minutes (4 hours).
[0047] The IDLE COUNT parameter indicates the duration that the
stimulator should remain idle after a therapy is performed in 10
minute increments and ranges from 0 minutes to 1440 minutes (24
hours).
[0048] The PULSE PERIOD parameter indicates what the delay or wait
count (FIG. 3) should be between pulses or bursts of pulses in 5 mS
increments and ranges from 3 to 100 (500 mS).
[0049] The PULSE STYLE parameter indicates the characteristics of
the pulse(s) that the pulse generator of the stimulator 10 is to
perform with the a bit indicating whether modulation is enabled (To
be enabled, the pulse count must be 1 and the duration must be
greater than 100 uS. For example, if the pulse width is 300 uS and
modulation is enabled, the pulse width will change from 300 uS,
then 200 uS, then 100 uS, back to 300 uS and repeat through the
completion of the therapy time), the three ccc bits indicating the
pulse count or number of pulses (FIG. 3), and the three ddd bits
indicating the pulse width or duration (FIG. 3) in 100 uS
increments from 100 to 700 uS.
[0050] The RECHARGE CONFIG parameter indicates the characteristics
of the 17 uS pulse(s) that used to recharge the pulse generator of
the stimulator 10 with the three bits aaa indicating the number of
recharging pulses (1-7), and the five bits bbbbb indicating the
number of 100 uS time duration increments or recharge intervals
(FIG. 3) between recharge pulses.
[0051] The RECHARGE COUNT parameter indicates the number of bursts
of recharge pulse(s) and ranges from 0-255.
[0052] The CHECKSUM parameter allows the processor to validate the
data contained in the memory block (MSB 0, LSB 0, MSB 1, LSB 1, MSB
2, LSB 2). For example, the processor can read the data from the
memory block and perform a predetermined algorithm on the [bits
that represent the] data. The result of this algorithm can then be
compared to the value in the checksum field. If the value in the
checksum field matches the result of the algorithm, then the data
that was read from the memory block is valid.
[0053] With reference to the software application of FIGS. 6-8, the
dialog box 300 used for programming the stimulator 10 via the pod
30 will now be described. The dialog box 300 includes a Patient
Information section 310 for identifying the patient and the patient
account number that the stimulator therapy data pertains to. The
Patient Information section 310 includes a Last Name text field 315
and a First Name text field 320 for inputting the patient's Last
Name and First Name respectively. The Patient Information section
310 also includes an Account Number text field 330 for inputting
the patient's account number.
[0054] The dialog box 300 includes a Therapy section 340 with a
Custom sub-section 350, a Time sub-section 360, a Next button 370,
and a Previous button 380. At the top of the Therapy section 340 is
a therapy number field 385 that identifies which numbered therapy
of the sequence of consecutively numbered therapies (e.g.,
therapies 1-16, therapies 1-64). To the right of the therapy number
field 385 is a therapy type field 390 with a drop-down menu of
different therapy types. The Custom sub-section 350 includes a
Pulses field 400, a Duration (uS) field 405, and a Period field
(mS) 410. All of these fields 400, 405, 410 include drop-down menus
for selecting a value to be entered in the fields. The Custom
sub-section 350 also includes a Pulse Polarity section 415 where a
Positive button 420, a Negative button 425, or a Bipolar button 430
may be actuated. The Time sub-section 360 includes a Therapy
section 435 and a Idle section 440 where time may be incrementally
increased or decreased in an hour field 445, 450 and a minute field
455, 460. Up and down arrow buttons in the Time subsection 360
allow the practitioner to adjust the hour and time.
[0055] The dialog box 300 also includes a End of Therapy section
465 with a Repeat button 470 and a Terminate button 475.
[0056] A Program button 480 in the lower-right corner may be
actuated to download the input and selected data to the stimulator
10 via the pod 30.
[0057] A method of programming the stimulator 10 will now be
described. The stimulator 10 is docked with the pod 30 as described
above and the pod 30 is communicatively coupled to the computer 40
(preferably a personal computer) through the connection 50. The
computer 40 is turned on and a software application is run on the
computer 40 to bring up the dialog box 300. The software
application is used to program and verify accurate programming of
the EEPROM memory in the stimulator 10 while the stimulator 10 is
docked in the pod 30. The dialog box 300 is used to program or
prescribe an electrical stimulation therapy for the patient into
the stimulator 10. The name of the patient is entered in the name
fields 315, 320 and the account number of the patient is entered in
the account number field 330.
[0058] As shown in FIG. 7, the practitioner opens the drop down
menu for therapy type field 390 and selects one of the therapy
types (e.g., TENS, Muscle Stim (EMS), Burst, Custom) for the first
therapy. Each therapy determined in turn by the practitioner may be
unique, or they may all be the same with different intensity
settings set manually by the practitioner after programming, or a
combination of both. In may cases, only a single therapy may be
programmed, but the capability for multiple therapies and custom
therapies is always available to the practitioner. The practitioner
may select a single simple predetermined therapy from the list of
therapy types or may select Custom and enter the parameters for a
custom therapy.
[0059] A therapy type not shown in the drop down menu in FIG. 7
that may be programmed into the stimulator 10 is a micro-current
therapy waveform for edema reduction or other complications. This
therapy may include a very low current/intensity output in a
pseudo-random bi-polar stimulation waveform. It has been determined
that the most effective treatment yielding long-term results is
subsensory. Such treatments are characterized by extremely low
frequencies (0.3 to 0.8 Hz) and intensities, and a biphasic (+/-)
waveform. In am embodiment of a micro-current stimulator, the
current level may range from 10 to 600 microamps. In preferred
embodiment, these treatments use less than {fraction (1/100)} of
the current levels of conventional electrical muscle stimulation
("EMS"). In a more preferred embodiment, these treatments use less
than {fraction (1/500)} of the current levels of conventional EMS.
In a most preferred embodiment, these treatments use about
{fraction (1/1000)} of the current levels of conventional EMS. The
output stimulation waveform may be "pseudo-random" in that it may
be periodic (e.g., 20 seconds on, alternating with 2 seconds off,
over a duration of time or continuously), but in that on time the
bi-polar output pulses have different pulse widths over different
time intervals. The micro-current therapy may be a separate version
of firmware, loaded via the pod 30 into the stimulator 10.
[0060] It should be noted, faster ON/OFF inter-cycle timing may
provided for EMS (electrical muscle stimulation) compared to TENS.
For example, during the on cycle in an EMS mode (bipolar), the
stimulation current may cycle on for up to 10 seconds and off for
up to 2 seconds as programmed parameters. Thus, if an EMS mode is
programmed to run on for 20 minutes and off for 1 hour, during the
20 minute on period, the stimulation current may cycle on for 2 to
10 seconds and off for 0 to 2 seconds in 1 second (or fractions of
a second) programmed increments.
[0061] With reference to FIG. 8, if Custom is selected, the fields
400, 405, 410 in the Custom sub-section 350 are activated and the
practitioner may select the desired parameters in this section 350.
The practitioner selects the number of pulses per wavefront by
using the drop-down menu in the pulses field 400, selects the pulse
duration by using the drop-down menu in the duration field 405, and
selects the time may then input the pulse polarity by selecting one
of the buttons 420, 425, 430 in the pulse polarity section 415.
[0062] The overall time duration of the therapy is input using the
up and down arrow buttons adjacent the hour field 445 and minute
field 455 (or by entering the time in these fields with the
keyboard) of the therapy section 435. Similarly, the time between
unique therapies or similar therapies is input using the up and
down arrow buttons adjacent the hour field 450 and minute field 460
(or by entering the time in these fields with the keyboard) of the
idle section 440.
[0063] The practitioner may select the terminate button 475 to
cause the stimulator 10 to terminate at the end of a programmed
session (elapsed minutes, hours or days) or select the repeat
button 470 to continuously repeat the programmed session until the
battery dies or the patient's next practitioner visit. The
practitioner selects the program button 480 to cause the programmed
session to be programmed into the persistent, modifiable memory of
the stimulator 10. A second therapy session, third therapy session,
etc. may be programmed in a like manner by paging between therapy
session dialog boxes with the next button 370 and the previous
button 380.
[0064] FIG. 9 is a block diagram illustrating an exemplary computer
40 as may be used in connection with various embodiments described
herein. For example, the computer 40 may be used in conjunction
with programming and verifying accurate programming of the
persistent, modifiable memory of the stimulator 10 in the manner
set forth above. However, other computers and/or architectures may
be used, as will be clear to those skilled in the art. Further, the
description of many of the elements of the computer 40 described
below (e.g., processor 552, main memory 556, secondary memory 558)
is applicable to corresponding elements in the stimulator 10 and
the pod 30.
[0065] The computer 40 preferably includes one or more processors,
such as processor 552. Additional processors may be provided, such
as an auxiliary processor to manage input/output, an auxiliary
processor to perform floating point mathematical operations, a
special-purpose microprocessor having an architecture suitable for
fast execution of signal processing algorithms (e.g., digital
signal processor), a slave processor subordinate to the main
processing system (e.g., back-end processor), an additional
microprocessor or controller for dual or multiple processor
systems, or a coprocessor. Such auxiliary processors may be
discrete processors or may be integrated with the processor
552.
[0066] The processor 552 is preferably connected to a communication
bus 554. The communication bus 554 may include a data channel for
facilitating information transfer between storage and other
peripheral components of the computer 40. The communication bus 554
further may provide a set of signals used for communication with
the processor 552, including a data bus, address bus, and control
bus (not shown). The communication bus 554 may comprise any
standard or non-standard bus architecture such as, for example, bus
architectures compliant with industry standard architecture
("ISA"), extended industry standard architecture ("EISA"), Micro
Channel Architecture ("MCA"), peripheral component interconnect
("PCI") local bus, or standards promulgated by the Institute of
Electrical and Electronics Engineers ("IEEE") including IEEE 488
general-purpose interface bus ("GPIB"), IEEE 696/S-100, and the
like.
[0067] Computer 40 preferably includes a main memory 556 and may
also include a secondary memory 558. The main memory 556 provides
storage of instructions and data for programs executing on the
processor 552. The main memory 556 is typically semiconductor-based
memory such as dynamic random access memory ("DRAM") and/or static
random access memory ("SRAM"). Other semiconductor-based memory
types include, for example, synchronous dynamic random access
memory ("SDRAM"), Rambus dynamic random access memory ("RDRAM"),
ferroelectric random access memory ("FRAM"), and the like,
including read only memory ("ROM").
[0068] The secondary memory 558 may optionally include a hard disk
drive 560 and/or a removable storage drive 562, for example a
floppy disk drive, a magnetic tape drive, a compact disc ("CD")
drive, a digital versatile disc ("DVD") drive, etc. The removable
storage drive 562 reads from and/or writes to a removable storage
medium 564 in a well-known manner. Removable storage medium 564 may
be, for example, a floppy disk, magnetic tape, CD, DVD, etc.
[0069] The removable storage medium 564 is preferably a computer
readable medium having stored thereon computer executable code
(i.e., software) and/or data. The computer software or data stored
on the removable storage medium 564 is read into the computer 40 as
electrical communication signals 578.
[0070] In alternative embodiments, secondary memory 558 may include
other similar means for allowing computer programs or other data or
instructions to be loaded into the computer 40. Such means may
include, for example, an external storage medium 572 and an
interface 570. Examples of external storage medium 572 may include
an external hard disk drive or an external optical drive, or and
external magneto-optical drive.
[0071] Other examples of secondary memory 558 may include
semiconductor-based memory such as programmable read-only memory
("PROM"), erasable programmable read-only memory ("EPROM"),
electrically erasable read-only memory ("EEPROM"), or flash memory
(block oriented memory similar to EEPROM). Also included are any
other removable storage units 572 and interfaces 570, which allow
software and data to be transferred from the removable storage unit
572 to the computer 40.
[0072] Computer 40 may also include a communication interface 574.
The communication interface 574 allows software and data to be
transferred between computer 40 and external devices (e.g.
printers), networks, or information sources. For example, computer
software or executable code may be transferred to computer 40 from
a network server via communication interface 574. Examples of
communication interface 574 include a modem, a network interface
card ("NIC"), a communications port, a PCMCIA slot and card, an
infrared interface, and an IEEE 1394 fire-wire, just to name a
few.
[0073] Communication interface 574 preferably implements industry
promulgated protocol standards, such as Ethernet IEEE 802
standards, Fiber Channel, digital subscriber line ("DSL"),
asynchronous digital subscriber line ("ADSL"), frame relay,
asynchronous transfer mode ("ATM"), integrated digital services
network ("ISDN"), personal communications services ("PCS"),
transmission control protocol/Internet protocol ("TCP/IP"), serial
line Internet protocol/point to point protocol ("SLIP/PPP"),
and
[0074] Software and data transferred via communication interface
574 are generally in the form of electrical communication signals
578. These signals 578 are preferably provided to communication
interface 574 via a communication channel 576. Communication
channel 576 carries signals 578 and can be implemented using a
variety of communication means including wire or cable, fiber
optics, conventional phone line, cellular phone link, radio
frequency (RF) link, or infrared link, just to name a few.
[0075] Computer executable code (i.e., computer programs or
software) is stored in the main memory 556 and/or the secondary
memory 558. Computer programs can also be received via
communication interface 574 and stored in the main memory 556
and/or the secondary memory 558. Such computer programs, when
executed, enable the computer 40 to perform the various functions
of the present invention as previously described.
[0076] In this description, the term "computer readable medium" is
used to refer to any media used to provide computer executable code
(e.g., software and computer programs) to the computer 40. Examples
of these media include main memory 556, secondary memory 558
(including hard disk drive 560, removable storage medium 564, and
external storage medium 572), and any peripheral device
communicatively coupled with communication interface 574 (including
a network information server or other network device). These
computer readable mediums are means for providing executable code,
programming instructions, and software to the computer 40.
[0077] In an embodiment that is implemented using software, the
software may be stored on a computer readable medium and loaded
into computer 40 by way of removable storage drive 562, interface
570, or communication interface 574. In such an embodiment, the
software is loaded into the computer 40 in the form of electrical
communication signals 578. The software, when executed by the
processor 552, preferably causes the processor 552 to perform the
inventive features and functions previously described herein.
[0078] Various embodiments may also be implemented primarily in
hardware using, for example, components such as application
specific integrated circuits ("ASICs"), or field programmable gate
arrays ("FPGAs"). Implementation of a hardware state machine
capable of performing the functions described herein will also be
apparent to those skilled in the relevant art. Various embodiments
may also be implemented using a combination of both hardware and
software.
[0079] It should be noted, although the stimulator 10 is described
as a transcutaneous electrical stimulator, the stimulator 10 may be
used for faradic, electromagnetic, or other forms of electrical
stimulation. Further, the stimulator 10 may be used as a device for
electroporation, electrophoresis, iontophoresis, and
electrochemical applications.
[0080] An important feature of the invention is the limited
controllability of the stimulator 10 by the patient. The battery
may not be replaceable by the patient and the only input control
given to patient related to therapy delivery is the ability to turn
the stimulator 10 on or off. Once the battery dies, the stimulator
10 is either disposed of or returned to the office of the
practitioner for return to a third party for refurbishing (e.g.,
environmentally responsible battery replacement, device integrity
testing). After refurbishing, the stimulator 10 is available for
reprogramming and reuse. Requiring a code (i.e., locking the
patient out from controlling the intensity) for enabling intensity
control and controlling intensity prevents the patient from
manually adjusting the intensity of the electrical signals to an
ineffective and/or dangerous level.
[0081] Another important feature of the invention is the
"prescription" nature of the programmed therapy, in that the
practitioner prescribes a specific therapy and the stimulator 10
provides the therapy at the prescribed intervals without patient
intervention. If the electrical pulses emitted by the stimulator
are uncomfortable to the patient, the patient simply turns the
stimulator 10 off with the "A" button (if the "A" button also
functions as an on/off switch), removes the stimulator 10, and
notifies the practitioner.
[0082] A further important feature of the invention is that the
stimulator 10 is considerably smaller, lighter, less cumbersome,
and less noticeable to the user or patient than stimulators used in
the past, increasing the comfort of the patient and increasing the
chances that the patient will use the stimulator 10.
[0083] It will be readily apparent to those skilled in the art that
still further changes and modifications in the actual concepts
described herein can readily be made without departing from the
spirit and scope of the invention as defined by the following
claims.
* * * * *